Remote Medical Writer: CSR & Regulatory Docs Expert

YO AI Labs; San Francisco (CA); Remote; USD 69,000 - 110,000; Full time

Job summary

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop and review regulatory documents with a focus on accuracy and compliance. The role involves interpreting protocols, ensuring ICH E3 alignment, and producing high-quality CSRs and related materials for regulatory submissions.

You will verify data against source documents, contribute to safety reports like DSURs/PSURs, and collaborate with cross-functional teams.

Qualifications

• 5+ years of regulatory medical writing experience in sponsor, CRO, or consulting environments.
• Experience authoring Clinical Study Reports (CSRs) and regulatory documentation.
• Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
• Demonstrated ability to assess scientific accuracy across source data and study reports.
• Experience with DSURs/PSURs and PK/PD data handling is a plus.

Responsibilities

• Author and review CSRs and other regulatory documents.
• Interpret clinical protocols and ensure ICH guideline compliance.
• Verify scientific accuracy using source data and TFLs.
• Review safety documentation including DSURs/PSURs/PBRERs.
• Provide structured feedback and collaborate with cross-functional teams.
• Support AI-assisted documentation evaluation and quality improvement initiatives.

Skills

Regulatory Medical Writing

CSR Authoring

ICH E3 Guidelines

Scientific Accuracy

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

eCTD Knowledge

Written Communication

Education

Advanced degree in Life Sciences/Medicine/Pharmacy

Job description

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop and review regulatory documents with a focus on accuracy and compliance. The role involves interpreting protocols, ensuring ICH E3 alignment, and producing high-quality CSRs and related materials for regulatory submissions.

You will verify data against source documents, contribute to safety reports like DSURs/PSURs, and collaborate with cross-functional teams.